NCT00979862

Cediranib Maleate and Cilengitide in Treating Patients With Progressive or Recurrent Glioblastoma

A Phase Ib Study of Cediranib in Combination With Cilengitide in Patients With Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of cediranib maleate when given together with cilengitide in treating patients with progressive or recurrent glioblastoma. Cediranib maleate and cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cediranib maleate together with cilengitide may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety profile of cediranib (cediranib maleate) in combination with cilengitide in patients with recurrent glioblastoma (Part A). SECONDARY OBJECTIVES: I. To estimate overall survival. II. To estimate the proportion of radiographic responses in recurrent glioblastoma patients with measurable disease treated with cediranib and cilengitide. III. To estimate the proportion of patients alive and progression free at 6 months (APF6) in patients with recurrent glioblastoma treated at the safe dose as determined in Part A (Part B). IV. To explore potential imaging techniques and biomarkers to capture the disease process through treatment. OUTLINE: This is a dose-escalation study of cediranib maleate. Patients are initially enrolled in the dose-finding portion of the study (part A). Once the safe dose of cediranib maleate is determined, additional patients are enrolled in the dose-expansion portion of the study (part B). Part A (dose finding): Patients receive cediranib maleate orally (PO) once daily on days 1-28 and cilengitide intravenously (IV) over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Part B (dose expansion): Patients are assigned to 1 of 2 groups according to prior anti-VEGF therapy (yes vs no). Patients in both groups receive cediranib maleate (administered at the safe dose determined in part A) and cilengitide as in part A. After completion of study therapy, patients are followed up every 2 months.

Conditions

• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Recurrent Adult Brain Neoplasm

Interventions

Type	Name	Description
DRUG	Cediranib Maleate	Given PO
DRUG	Cilengitide	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-05-01
• Completion: 2014-02-01
• First posted: 2009-09-18
• Last updated: 2015-04-15

Locations

11 sites across 1 country: United States